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HPLC Analysis of Humira on BIOshell™ A400 Protein C4 Column

HPLC Analysis of Humira on BIOshell™ A400 Protein C4 Column

Conditions

column BIOshell A400 Protein C4, 10 cm x 2.1 mm, 3.4 µm particles (66825-U)
column temp. 75 C
mobile phase [A] 80:20, (water, 0.1% TFA): (acetonitrile, 0.1% TFA); [B] 50:50, (water, 0.1% TFA):(acetonitrile, 0.1% TFA).
gradient 45 to 57% B in 12 min
flow rate 0.2 ml/min
pressure 2450 psi (for Competitor A), 1230 psi for BIOshell (169 bar (for Competitor A), 85 bar for BIOshell)
sample 0.3 µl Humira

Description

Analysis Note Humira is a biotherapeutic used to treat rheumatoid arthritis (RA), ulcerative colitis (UC), and chronic plaque psoriasis (Ps). Analysis of the mAb′s monomors, aggregates, and fragments was performed on a BIOshell A400 Protein C4 column as well as a comparable column on the market. The BIOshell A400 Protein C4 column shows greater retentivity as well as greater resolution of the monomer from the aggregates and drug fragments. Peak recoveries were essential equivalent for the two columns.
Categories Analytical Chromatography, Proteins
Featured Industry Life Science and Biopharma
Legal Information BIOshell is a trademark of Sigma-Aldrich Co. LLC
Other Notes mAb diluted in 20 mM Tricine/KOH, pH 7 to 1 g/L
suitability application for HPLC

Materials

     
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